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Senior Regulatory Affairs Associate- Clinical Trial Application

Parexel · bengaluru, karnataka, India

Location
bengaluru
Job Type
Full-time
Posted
June 17, 2026

Job Description

When our values align, there's no limit to what we can achieve.
 

Job Summary:

The Clinical Trial Submission Lead (CTSL) is responsible for end-to-end planning, coordination, and execution of Clinical Trial Applications (CTA) across EU CTR and Rest of the World (ROW) regions. This role ensures timely, high-quality, and compliant submissions through effective cross-functional collaboration, proactive risk management, and strong regulatory expertise.

Key Responsibilities:

  • Lead end-to-end CTA project management across multiple studies and countries
  • Plan, track, and deliver submissions aligned with timelines and regulatory requirements
  • Manage risks, dependencies, and complexities in global regulatory environments
  • Apply knowledge of EU CTR and ROW CTA requirements
  • Manage core clinical and regulatory documentation
  • Collaborate with cross-functional global teams
  • Build and main...

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